Simulations Plus - Q3 2024

Transcript

Operator (participant)

...Greetings, and welcome to the Simulations Plus third quarter fiscal 2024 financial results conference call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. It is now my pleasure to introduce Lisa Fortuna from Financial Profiles. Ms. Fortuna, you may begin.

Lisa Fortuna (Head of Investor Relations)

Good afternoon, everyone. Welcome to the Simulations Plus third quarter fiscal 2024 financial results conference call. With me today are Shawn O'Connor, Chief Executive Officer, and Will Frederick, Chief Financial Officer and Chief Operating Officer of Simulations Plus. Please note that we updated our quarterly earnings presentation, which will serve as a supplement to today's prepared remarks. You can access the presentation on our investor relations website at www.simulations-plus.com. After management's commentary, we will open the call for questions. As a reminder, the information discussed today may include forward-looking statements that involve risks and uncertainties. Words like believe, expect, and anticipates refer to our best estimates as of this call, and actual future results could differ significantly from these statements. Further information on the company's risk factors is contained in the company's quarterly and annual reports, and filed with the Securities and Exchange Commission.

With that, I'll turn the call over to Shawn O'Connor. Please go ahead.

Shawn O'Connor (CEO)

Thank you, Lisa. Good afternoon, everyone, and thank you for joining our third quarter fiscal 2024 conference call. Results for the third quarter of fiscal 2024 were in line with our internal guidance. Strong performance in both our software and services segments delivered solid revenue growth of 14%, diluted earnings per share of $0.15, and adjusted diluted earnings per share of $0.19. Given our solid performance in the first nine months and the acquisition of Proficiency, we are on track to achieve our recently revised full-year revenue guidance. As we noted last quarter, the market funding environment continues to improve over last year. Biotech funding is starting to show signs of recovery, most notably for companies that have drug candidates in the clinic. We continue to be cautiously optimistic about our large pharmaceutical client spending.

Right now, we see a range of spending patterns among large pharmaceutical companies. Some are increasing expenditures, others remain conservative, and with most falling somewhere in between, depending on various internal and external market factors. Overall, the market is in a better position today compared to a year ago. Moving to our software segment. Software revenues increased 12% in the third quarter and were up 14% for the 9-month period. We saw good renewals, upsells, and new logo activity. However, there has been some impact from ongoing churn in small biotech, and the Asian market still continues to lag overall market growth. Our Cheminformatics business unit delivered 15% revenue growth in the third quarter and 12% for the fiscal year to date. This quarter's growth was once again driven by higher revenues for ADMET Predictor.

Additionally, there were 15 new customers and 10 upsells for this business unit in Q3. Our physiologically based pharmacokinetics, or PBPK business unit, had a 7% revenue increase in the third quarter and 9% for the fiscal year to date. The PBPK business unit added 14 new customers and booked eight upsells with existing customers. We were excited to launch GPX, the next generation of physiologically based pharmacokinetics, biopharmaceutics, modeling and simulation software, and believe it will become a meaningful addition to our suite of leading-edge solutions. Initial client reaction has been very positive. Our clinical pharmacology and pharmacometrics, or CPP business unit, grew 13% during the quarter and 18% for the fiscal year to date. During the quarter, we added 13 new customers and had three customer upsells.

Revenues in our quantitative systems pharmacology, or QSP business unit, increased 80% for the quarter and 78% for the fiscal year to date. As a reminder, quarterly results can be lumpy for QSP based on the high ticket price per license and a smaller pool of end users. Turning to our services segment, revenues increased 18% during the third quarter and 21% for the nine-month period, with solid bookings and a healthy pipeline of active opportunities. Our large pharma clients continue to exhibit cautious spending patterns, but we're seeing good lead activity, which is a positive sign. Total backlog at the end of the third quarter was $19.6 million, which is a robust level as we enter the final quarter of our fiscal year.

Services revenues in our CPP business unit were strong, up 27% in the third quarter and 16% for the fiscal year to date. In our QSP business unit, services revenue grew 49% in the third quarter and 74% for the nine-month period, benefiting from immunology and oncology model projects.... Services revenue in our PBPK business unit decreased 10% for the third quarter and increased 4% for the fiscal year to date. We continue to encounter client source data delays impacting the initiation of contracted projects. Moving on to our recent news. On June 12, we announced the acquisition of Proficiency, a leader in providing simulation-enabled performance and intelligence solutions for clinical and commercial drug development. The acquisition brings together our collective expertise in simulations, AI technologies, and a focus on science, creating a one-of-a-kind platform that spans across the drug development continuum.

Although it's only been a few weeks, we're pleased that the Proficiency, integration, and collaboration are progressing in line with our internal plan and schedule. Additionally, our customers are showing interest in learning more. We will be able to provide a fuller update on our year-end call in October. With that, I'll turn the call over to Will.

Will Frederick (CFO and COO)

Thank you, Shawn. To recap our strong third quarter performance, total revenue increased 14% to $18.5 million. Software revenue increased 12%, representing 64% of total revenue, and services revenue increased 18%. On a trailing twelve-month basis, total revenue increased 20% to $67 million. Software revenue increased 22%, representing 60% of total revenue, and services revenue increased 17%. Q3 total gross margin was 71%, compared to 82% last year, with software gross margin at 88% versus 91%, and services gross margin at 41% versus 63%. For the trailing twelve months, total gross margin was 73%, software gross margin was 88%, and services gross margin was 48%.

The year-over-year services gross margin decline was primarily driven by the previously communicated shift of our services personnel to cost of revenue departments from SG&A departments. Turning to software revenue contribution by business unit for the quarter, PBPK was 56%, Cheminformatics was 20%, CPP was 18%, and QSP was 6%. For the trailing twelve months, PBPK contribution was 54%, CPP was 20%, Cheminformatics was 19%, and QSP was 7%. For the trailing twelve months, our customer renewal rate was 92% based on fees and 84% based on accounts. For the trailing twelve months, average revenue per customer increased to $95,000. Shifting to our services revenue contribution by business unit for the quarter, CPP was 48%, QSP was 29%, PBPK was 19%, and Reg was 4%.

For the trailing twelve months, CPP contribution was 44%, QSP was 31%, PBPK was 21%, and Reg was 4%. Total services projects worked on during the quarter were 181, and quarter-end backlog increased to $19.6 million. Anticipated revenue from backlog within twelve months increased to approximately 91%. Turning to our consolidated income statement for the quarter, R&D expense was 7% of revenue, compared to 6% last year. Sales and marketing expense was 13% of revenue, up from 10% last year, and G&A expense was 41% of revenue, up marginally from 40% last year. G&A expense for the quarter included $0.9 million of transaction-related expenses for the acquisition of Proficiency. Total operating expenses were 61% of revenue, compared to 57% last year.

Income from operations was 10% of revenue, compared to 25% last year, and income before income taxes was 21% of revenue, compared to 30% last year. Year-over-year expense increases were primarily due to the Proficiency acquisition costs and cash and stock-based compensation increases due to headcount additions, primarily from the Immunetrics acquisition last year. Other income was $2 million this quarter, compared to $0.8 million last year, primarily due to a $0.6 million increase from lower fair value of the Immunetrics earn out liability and a $0.4 million increase from higher interest income. Net income for the third quarter was $3.1 million, or 17% of revenue, compared to $4 million or 25% of revenue last year.

Diluted earnings per share were $0.15, compared to $0.20 last year, and adjusted diluted EPS, excluding the impact of acquisition costs, were $0.19 compared to $0.21 last year. Third quarter adjusted EBITDA was $5.7 million, compared to $6.5 million last year, at 31% and 40% of revenue, respectively. We calculate adjusted EBITDA by adding back interest, taxes, depreciation, and amortization, stock-based compensation, gain or loss on currency exchange, any acquisition or financial transaction-related expenses, and any asset impairment charges. The reconciliation of this non-GAAP metric to net income, the relevant GAAP metric, is in our earnings release and on our website. Income tax expense for the third quarter was $0.8 million, compared to $0.9 million last year, and our effective tax rate remained constant at 19%.

Our current effective tax rate estimate for the full fiscal year remains between 20%-23%. Turning to our balance sheet, we ended the quarter with $119 million in cash and investments. Following the acquisition of Proficiency in June, we had $19 million in cash and investments and remain well capitalized with no debt, strong free cash flow, and a continued commitment to our capital allocation strategy and corporate development initiative. Lastly, today, we announced that our board of directors has determined to discontinue the company's quarterly cash dividend with the final payment in August. The board's decision reflects our priority to invest in growth initiatives that will generate long-term shareholder value versus continuing the nominal dividend. I'll now turn the call back to Shawn.

Shawn O'Connor (CEO)

Thank you, Will. Our third quarter results reflected strong performance in both our software and services segments. As we said last quarter, market conditions have improved compared to last year, but these changes require time before they translate to actual bookings and revenue. As such, we remain cautiously optimistic. With our strong performance in the first nine months of the year, combined with the expected $3 million contribution from Proficiency in the newly formed Clinical Simulations and Medical Communications business unit, we are well positioned to meet our stated fiscal 2024 guidance targets, which include total revenue between $69 million-$72 million, year-over-year revenue growth in the range of 15%-20%, software mix between 55%-60%, services mix between 40%-45%, diluted earnings per share of $0.46-$0.48, and adjusted diluted earnings per share of $0.54-$0.56.

Of note, we are adding adjusted EPS to provide clarity on our operating profitability and separate the impact of transaction costs related to the Proficiency acquisition. Our GAAP guidance reflects an adjustment to diluted EPS to reflect the GAAP impact of these same acquisition-related charges and the fourth quarter reporting, which consolidates the acquisition. We will be providing our fiscal year 2025 guidance in October when we report our fourth quarter and full year fiscal 2024 results, but are reaffirming that the acquisition of Proficiency is expected to be accretive to our fiscal year 2025 EPS, factoring in the loss of interest income. Before turning to the Q&A, I want to take the opportunity to reinforce the key differentiators of our story. Simulations Plus is a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications for the biopharma industry.

The new CSMC business unit brings experience in content simulation developed with AI technologies to enhance clinical trial success, data analytics, and medical communications. With the acquisition, we have doubled our total addressable market to $8 billion and have expanded our portfolio to serve pharma clients from the preclinical phase through to commercialization. We have a compelling customer value proposition and strong competitive position with high barriers to entry. We have an attractive financial profile, a strong balance sheet and no debt. And finally, we have a seasoned management team with scientific leadership and significant expertise in modeling and simulation. Thank you for your time today. And with that, I'll now turn the call over to the operator for your questions.

Operator (participant)

Thank you, Mr. O'Connor. We'll now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Thank you. Our first question is from Max Smock with William Blair. Please proceed with your question.

Christine Rains (Healthcare Equity Research Analyst)

Hi, it's Christine Rains on for Max Smock. Thanks for taking our questions. While I understand you're not providing guidance today, on a high level, how should we think about 2025 organic revenue growth potential given current improving macro environment and bookings and backlog visibility? Also on the inorganic side, are you still thinking about a $15 million-$18 million contribution from Proficiency in 2025? And how should we think about the cadence and breakdown between software versus services? Thanks.

Shawn O'Connor (CEO)

... Yeah, thank you much for the question. And, yeah, I know everyone is anxious, but we do give guidance in October for fiscal year 2025. You know, from a, you know, step back, objective, sort of perspective, we've always stated that a growth rate, biosimulation market as a whole is growing 12%-15%. And in the last two years, we've given guidance of 10%-15% in a difficult market. You know, the potential exists for the market improvement that we're starting to see this year to help contribute to an advancement of that in fiscal year 2025.

But we've really not seen that translate into you know bookings and activity as yet this year, so remain cautious in that regard. Certainly, the funding in biotech has improved, and that's a more active environment. But the large pharma market, which makes up the majority of our client base, still is a you know a mixture of spenders and non-spenders, with most people pretty much holding tight.

So as we enter the year in October, our timing in terms of giving guidance benefits from the fact that as we enter the back half of the year, our clients start going through their fiscal year 2025 budgeting cycles, and we get some visibility to that, and that always contributes to our ability to give guidance into next year. No change in what we've said in terms of the Proficiency contribution in fiscal 2025. The $15 million-$18 million we said at the announcement of the transaction. Certainly potential for that number to come in better than that. But at this point in time, you know, $15 million-$18 million is our expectation.

Christine Rains (Healthcare Equity Research Analyst)

Great, thanks. That, that makes a lot of sense. On margins, we were a little surprised to see Adjusted EBITDA margin come in a little short of expectations, despite outperformance in software revenue. So hoping you can provide some more color on key puts and takes impacting margins in the quarter.

Shawn O'Connor (CEO)

Yeah, it's, you know, it's come down a bit. You know, we've been the last couple of quarters at 31-32% level in terms of adjusted EBITDA. And we certainly target that to be in the 30%-35%-40% range. You know, temporary sort of situations contributions in terms of expenses, we had a pretty significant software release during the quarter of GPX to the marketplace that had some costs associated with that. We're benefiting, quite frankly, globally from incredible retention and recruiting efforts, and you know, seeing very little churn in terms of our employee base.

And, you know, typically, we see more of that, and, so our hiring up has accumulated more quickly this year. That's contributing a little bit to it, and, we'll even out over the course of the coming quarters. So, you know, those two factors, I think, are contributing a bit there. But, you know, we remain targeted in the 35%-40% range. And as I said with the announcement, Proficiency will add a little bit of pressure to that in the beginning. But, we believe that they will fit our long-term profile as well.

Christine Rains (Healthcare Equity Research Analyst)

Great. That's also helpful. Just one last one for us. On the PBPK services side, with that being down this quarter due to client-sourced data delays impacting the initiation of contracted projects, just confirming that this work is delayed and not canceled. And if so, should we expect the benefit from this work materializing in Q4 or 2025?

Shawn O'Connor (CEO)

Well, we hope to get back on track with a more consistent, even flow, PBPK consulting business. If you look back over a 4-8 quarter trend line, they were contributing a very significant growth quarter-over-quarter for a good part of that window of time. We've encountered of late some contractual situations that the expectations in terms of data readiness to perform those projects has been pushed off. Nothing significant in terms of cancellation of those projects, but delay. Whether that delay catches up in the fourth quarter, you know, is to be seen and experienced there.

If it all caught up, we might be a little challenged in terms of capacity, in that regard. But you know, we've had two quarters, maybe two and a half quarters of delays impacting that segment. It tends to cycle through our CPP consulting practice, our QSP consulting practice. We seem to always have one that has some delay challenges. And that portfolio consulting services usually evens out, and as with this quarter, their growth at 18% was quite strong.

Christine Rains (Healthcare Equity Research Analyst)

Great. Thank you for taking our questions.

Shawn O'Connor (CEO)

Sure.

Operator (participant)

Thank you. Our next question is from Francois Brisebois with Oppenheimer and Company. Please proceed with your question.

Francois Brisebois (Analyst)

Hi, thanks for taking the questions. So I was just wondering, in terms of the market as a whole, biotech, pharma, the XBI and IBB, they've kind of, you know, come back a little bit after the first quarter, was pretty exciting for the space. So I was just wondering, in terms of your feel for market and then potential upside, your cautious optimism, is this based on where we are now? Have you seen anything, or was it kind of more exciting after the first quarter, and now we're a little more cautious? Any color there would be helpful.

Shawn O'Connor (CEO)

Yeah, Frank, you know, the two segments, one at a time. On the biotech side, boy, the excitement of seeing that funding, those funding announcements, was very positive. That seems to have leveled out, I guess, not gone away, but leveled out. And you know, we're still really waiting for that to translate into contracted business. Certainly more conversations and pipeline activity there that bodes well for the future. But in terms of that translating to, you know, anything different from the growth, the baseline growth, if you will, that we've been experiencing in that segment over the last few quarters, that's yet to come.

On the large pharma side, again, you know, we just each account is its own anecdotal story in terms of budget process and cutbacks and pace. You know, in those situations, at least from a historical perspective, we often see that where the large pharma external or internal announcement of cutback in terms of expenses creates a window, a pause of time in which purchasing activity contracting new business slows down. Oftentimes, that leads to a flurry as they catch up, and programs are still being pushed forward, and they need to contribute to the modeling and simulation input into those clinical trial efforts, but they can't just go away.

So, are we, you know, more optimistic or more cautious today? We're continuing to work hard within the environment that we've got. Boy, there are some bright lines out there in terms of some improvements, but, you know, a continuous flow of challenging budgetary decisions on the part of our clients keeps us probably in the same framework of mind that we were in the last quarter or two.

Francois Brisebois (Analyst)

Okay, thank you. Then, maybe lastly, in terms of the Proficiency update that you mentioned on the next call, is that all related to guidance or, you know, what else in terms of updates should we be expecting here from that acquisition? And maybe if you could just touch on the guidance updates, just to clarify here, in terms of the EPS, versus what you had announced, is that just related to the acquisition? Just any clarity there on the updated diluted EPS would be helpful. Thanks.

Shawn O'Connor (CEO)

Yeah, yeah. Referring to Proficiency in terms of our guidance into 2025, certainly this will be our first quarter in which they contribute to our quarterly financial results. So they will come into our commentary just as our other business units. So in October, we'll comment on progress in terms of the integration of Proficiency as well as its operating success during the fourth quarter. And it will be included, and we'll give a little bit more detail to its contribution in fiscal year 2025 coming up. On the breakout of the EPS, the adjusted non-GAAP EPS, as well as the diluted EPS.

Yeah, a change there to, you know, you know, some confusing questions in terms of, when we announced the, change there, to provide more clarity in terms of the, mix between, the impacts of the interest income, going away and the, and the transaction costs.

Francois Brisebois (Analyst)

Thank you.

Operator (participant)

Thank you. Our next question is from Matt Hewitt with Craig-Hallum. Please proceed with your question.

Matt Hewitt (Senior Research Analyst)

Good afternoon. Thank you for taking the questions. Maybe first up, regarding Proficiency, I think, when you provided the acquisition call, you spoke a little bit about how their margins, particularly their gross margins, are a little bit below, Simulations Plus's historic margins. And I think you had commented that over time, you expect those to get in line with the company. I think you even mentioned that today. Is that gonna be a gradual, kind of improvement in the Proficiency, or is there some type of a trigger event that would get those to snap in line, on a faster pace?

Shawn O'Connor (CEO)

Yeah, Matt, little bit of both, I guess. You know, the profile of their, their margin is, you know, call it, call it similar to like our acquisition of Immunetrics, where you've got a business that's contributing both software and service revenues. And so, their margin is impacted by that mix between higher margin software and lower margin consulting revenue dollars. And their margin is impacted by, you know, operating efficiencies that are being worked in both sides of the business. Most notably, continued investment in the technology side, the software side. Their software margin is closer to 80% versus our 90% on the software side.... and, you know, that's kind of a step function in terms of its improvement as it's mapped out.

They've improved quite significantly over the last 12-18 months, getting to 80% by the use of technologies to accelerate, automate, use AI to translate protocol into their training modules that are licensed to clients. And work is continuous in that regard. And so we see a path getting them to our sort of 90% level in terms of software margin. And the growth rate of those revenue dollars affects that mix, which is more heavily skewed towards service than our overall 60/40 split of software versus consulting revenues, service revenues. And so that growth rate will help catch up and impact the overall margin that they contribute as well over time.

So, we start out at a low point, if you will, and it will be mostly gradual through into next year, and beyond. But as they release the improvements on the technology side, there'll probably be a little bit of stair step as we move through fiscal year 25.

Matt Hewitt (Senior Research Analyst)

Got it. Then maybe one question. Again, I think you mentioned on your call, you've mentioned again this afternoon regarding Proficiency being accretive to fiscal 25 earnings. I'm just curious off of what base? And I, I assume you're referencing the GAAP numbers in that. But are you talking off of fiscal 24, it's gonna be accretive? Is it based on accretive to where consensus was prior to today? Just curious what the base was on the accretive guidance for next year. Thank you.

Shawn O'Connor (CEO)

Yeah, we reinforced in the script that it's accretive in terms of covering the lost interest income that we've been enjoying while those dollars were sitting in investment on our balance sheet. So they will be accretive and contribute positively to earnings per share, covering interest income.

Matt Hewitt (Senior Research Analyst)

Got it. All right. Thank you.

Operator (participant)

Thank you. Our next question is from David Larsen with BTIG. Please proceed with your question.

David Larsen (Managing Director and Healthcare IT and Digital Health Analyst)

Hi, congrats on the revenue beat relative to our model this quarter. Can you maybe just clarify, with the EPS guide, was that changed on an apples-to-apples basis relative to the June 12 commentary? Because I had thought that in fiscal 2Q, we were at $0.66-$0.68, and then on June 12, it declined by about $0.12 to $0.54-$0.56 because of the lower interest income and the transaction costs. And now we're at, I think it's $0.46-$0.48 GAAP, $0.54-$0.56 adjusted. But if the $0.54-$0.56 is adjusted and we're adding back the transaction costs, just it. Was the EPS guide lowered or not? Just how are you thinking about that, please? Thank you.

Shawn O'Connor (CEO)

Yeah, well, I'll, I'll ask you to, to contribute here as well. I know that, our expectation in terms of transaction costs was, you know, a little higher coming in, in terms of, the expense that's gonna hit in the fourth quarter, and that contributed, there as well. But, Willie, you want to, add any color here?

Will Frederick (CFO and COO)

Sure. Happy to answer, David. The apples to apples, where we had the $0.54-$0.56 on the diluted, and now we've got $0.46-$0.48, as Chris, as Shawn was mentioning. The transaction costs, once we had all the numbers in, as well as the purchase price allocation got completed, and so we had visibility, better visibility into the amortization costs for the quarter. We just adjusted that to the $0.46-$0.48. And then to make sure that we had clarity with regards to what the adjusted EPS would look like without those costs, that's the $0.54-$0.56.

David Larsen (Managing Director and Healthcare IT and Digital Health Analyst)

Okay. So it sounds like transaction costs, which are obviously one-time non-recurring, came in a little bit higher than expected. If we exclude those, we're at $0.54-$0.56. Okay. And then the G&A costs increased quite a bit sequentially, I think, from, like, $5.5 million in fiscal 2Q to, is it $7.7 million? So up more than $2 million sequentially, I think, and the stock comp, I think, is up about $100,000 sequentially. Am I reading that correctly? And what drove the higher G&A?

Will Frederick (CFO and COO)

Yeah, the primary driver there is the hiring of employees, as, as well as year-over-year, we brought on the Immunetrics folks. So in Q3 of this year, we've got the Immunetrics team. It was about 20 employees that we brought on in Q4 of last year. So we certainly have more employees with about 210 or so at this point compared to last year. So most of it's comp costs.

David Larsen (Managing Director and Healthcare IT and Digital Health Analyst)

... okay, and I think it's another million from transaction costs in that SG&A number, sequentially. Okay. And then, Shawn, I think I heard you say 35%-40% for the sort of longer term adjusted EBITDA margin expectation. Is that correct?

Shawn O'Connor (CEO)

Yeah, that's where we have historically operated in the past, and that's always been our target. We've been in, you know, below the 35, you know, beginning in the timeframe in which we had compensation creep in the marketplace and had to accelerate the compensation programs there, and have been gradually moving that back up. But that's the target that we still shoot for, 35%-40%.

David Larsen (Managing Director and Healthcare IT and Digital Health Analyst)

Okay. And then just broadly speaking, I guess, in terms of the demand environment, it sounds like things are accelerating and picking up. Just, will Proficiency add that, add to that? It sounds like Proficiency is more of like a key opinion leader, sales and marketing type of solution. Just any color on the demand environment would be great.

Shawn O'Connor (CEO)

You know, certainly the software side of the business is tied to clinical trial activity as well. So some of the drivers there are common to ours as well. And so the same purse strings in terms of pushing drugs through the clinical process will also push their revenue growth as well.

David Larsen (Managing Director and Healthcare IT and Digital Health Analyst)

Okay, appreciate it. Congrats on a good quarter. Thank you.

Shawn O'Connor (CEO)

Very good.

Operator (participant)

Thank you. There are no further questions at this time. I'd like to hand the floor back over to Mr. Shawn O'Connor for closing comments.

Shawn O'Connor (CEO)

Okay, very good. Well, I appreciate everyone's attention and look forward to speaking again, as we close our fiscal year in October. Take care, everyone.

Operator (participant)

This concludes today's conference. You may disconnect your lines at this time. Thank you for joining us today.